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The main objective of the study is to evaluate the effect on intestinal permeability of a supplementation with Lactibiane Tolérance® for 4 weeks (28 days) in patients suffering from irritable bowel syndrome (IBS) with diarrhea predominance.
Secondary objectives of the study are to evaluate the effects of supplementation with Lactibiane Tolérance® for 4 weeks (28 days) in patients suffering from IBS with diarrhea predominance on intestinal permeability, inflammation of the digestive tract, symptoms and comfort.
Single-center study in single open arms: 30 volunteer adults suffering from Irritable Bowel Syndrome (IBS) with diarrhea predominance and matching the criteria of inclusion and non-inclusion listed below.
single-center pilot study in single open arm:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | Supplementation with Lactibiane Tolerance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactibiane Tolerance | Dietary Supplement | probiotics |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of intestinal permeability | Evolution between V1 and V2 of intestinal permeability evaluated by the lactulose-mannitol test according to the slope of urinary excretion of ingested lactulose percentage (calculated by linear regression) during the period representing the passage into the small intestine (2 to 4 hours after ingestion of lactulose-mannitol mixture). | at day 0 and day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of intestinal permeability - secondary 1 | Evolution of slope percentages urinary excretion (UE) of ingested mannitol ([M]) (calculated by linear regression) during the period representing the Passage Into the Small Intestine (PISI) (2 to 4 hours (h) after ingestion of [L]-[M] mixture) | at day 0 and day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Parameters measured ex vivo from colonic biopsies placed in Ussing chamber : change from baseline of paracellular permeability | Evolution of the slope ( determined by linear regression ) and area under the curve of evolution of the concentration of sulfonic acid fluorescence (measured in the basolateral chamber ) over time (measured every 30 min for 3 hours ) | at day 0 and day 28 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Coron Emmanuel, Pr. | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU-Hôtel-Dieu, Service d'Hépato-gastro-entérologie | Nantes | 44093 | France |
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| Change from baseline of intestinal permeability - secondary 2 |
Evolution of the ratio between the slopes of the UE percentages of lactulose ([L]) and [M] ingested during the PISI (2 to 4h after ingestion of lactulose-mannitol mixture) |
| at day 0 and day 28 |
| Change from baseline of intestinal permeability - secondary 3 | Evolution of the percentage of UE of [L] ingested on the excretion of ingested [M] during the period representing the PISI (2 to 4h after ingestion) | at day 0 and day 28 |
| Change from baseline of intestinal permeability - secondary 4 | Evolution of the UE percentage of [L] ingested on the UE of ingested [M] each lap of the period representing the PISI | at day 0 and day 28 |
| Change from baseline of intestinal permeability - secondary 5 | Evolution of he percent UE of [L] ingested on the UE of ingested [M] during the period representing the passage in the colon (between 4 and 5h after ingestion) | at day 0 and day 28 |
| Change from baseline of intestinal permeability - secondary 6 | Evolution of the percent UE of [L] ingested on the UE of ingested [M] during the period of 5h after ingestion | at day 0 and day 28 |
| Change from baseline of intestinal permeability - secondary 7 | Evolution of the UE percentage of [L] ingested on the UE of ingested [M] during the transition period representative of the stomach to the small intestine (between 0 and 2h after | at day 0 and day 28 |
| Change from baseline of intestinal permeability - secondary 8 | Evolution of the Percentage of UE of [L] and [M] ingested during the period representing the PISI (2 to 4h after ingestion) | at day 0 and day 28 |
| Change from baseline of intestinal permeability - secondary 9 | Evolution of the Percentage of UE of [L] and [M] ingested during a period of 5h after ingestion | at day 0 and day 28 |
| Change from baseline of intestinal permeability - secondary 10 | Evolution of the Percentage of UE of [L] and [M] ingested each 5h lap | at day 0 and day 28 |
| Change from the baseline of the inflammatory status - secondary 11 | Evolution between V1 and V2 of inflammatory status by fecal calprotectin | at day 0 and day 28 |
| Change from the baseline of the symptomatology - secondary 12 | Time to onset of the first colored red stool after taking carmine red capsules (minutes) | at week 0 and week 4 |
| Change from the baseline of the symptomatology - secondary 13 | Average intensity of 7 days of the worst abdominal pain on Likert scale (11 points) | at week 0 and week 4 |
| Change from the baseline of the symptomatology - secondary 14 | Medium intensity of 7 days of abdominal discomfort on Likert scale (11 points) | at week 0 and week 4 |
| Change from the baseline of the symptomatology - secondary 15 | Stool consistency average of 7 days after Bristol Stool Scale (BSS) | at week 0 and week 4 |
| Change from the baseline of the symptomatology - secondary 16 | Mean daily stool frequency of 7 days after BSS quiz | at week 0 and week 4 |
| Parameters measured ex vivo from colonic biopsies placed in Ussing : change from baseline of transcellular permeability | Evolution of the slope ( calculated by linear regression) and area under the curve of evolution of the concentration of Horse Radish Peroxidase (HRP) (measured in the basolateral chamber ) over time (measured every 30 minutes between 1 and 3 hours) . | at day 0 and day 28 |